Label: REHYDRATE- avena sativa, equisetum hyemale, hypericum perforatum, ulmus fulva, glycyrrhiza glabra, pueraria lobata, wildbad aqua, carlsbad aqua liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 54638-0001-1 - Packager: ParaDocs All Natural Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.
Drug Label Information
Updated August 7, 2013
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- ACTIVE INGREDIENTS:
- INDICATIONS:
- WARNINGS:
- STORAGE:
- DIRECTIONS:
- INACTIVE INGREDIENTS:
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INGREDIENTS AND APPEARANCE
REHYDRATE
avena sativa, equisetum hyemale, hypericum perforatum, ulmus fulva, glycyrrhiza glabra, pueraria lobata, wildbad aqua, carlsbad aqua liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54638-0001 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F) AVENA SATIVA FLOWERING TOP 3 [hp_X] in 1 mL EQUISETUM HYEMALE (UNII: 59677RXH25) (EQUISETUM HYEMALE - UNII:59677RXH25) EQUISETUM HYEMALE 4 [hp_X] in 1 mL HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM 6 [hp_X] in 1 mL ULMUS RUBRA BARK (UNII: 91QY4PXU8Q) (ULMUS RUBRA BARK - UNII:91QY4PXU8Q) ULMUS RUBRA BARK 6 [hp_X] in 1 mL GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) (GLYCYRRHIZA GLABRA - UNII:2788Z9758H) GLYCYRRHIZA GLABRA 12 [hp_X] in 1 mL PUERARIA MONTANA VAR. LOBATA WHOLE (UNII: D295OFK7E1) (PUERARIA MONTANA VAR. LOBATA WHOLE - UNII:D295OFK7E1) PUERARIA MONTANA VAR. LOBATA WHOLE 12 [hp_X] in 1 mL WATER (UNII: 059QF0KO0R) (WATER - UNII:059QF0KO0R) WATER 6 [hp_C] in 1 mL ADENOSINE TRIPHOSPHATE (UNII: 8L70Q75FXE) (ADENOSINE TRIPHOSPHATE - UNII:8L70Q75FXE) ADENOSINE TRIPHOSPHATE 30 [hp_C] in 1 mL GERMANIUM SESQUIOXIDE (UNII: 96WE91N25T) (GERMANIUM SESQUIOXIDE - UNII:96WE91N25T) GERMANIUM SESQUIOXIDE 30 [hp_C] in 1 mL HYDROGEN (UNII: 7YNJ3PO35Z) (HYDROGEN - UNII:7YNJ3PO35Z) HYDROGEN 30 [hp_C] in 1 mL OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN 30 [hp_C] in 1 mL Inactive Ingredients Ingredient Name Strength BETA VULGARIS (UNII: 4G174V5051) CENTAUREA BENEDICTA FLOWERING TOP (UNII: NJN80GZ34N) PEUMUS BOLDUS LEAF (UNII: Q4EWM09M3O) CHELIDONIUM MAJUS FLOWERING TOP (UNII: O9HP59XU7F) TARAXACUM OFFICINALE ROOT (UNII: 9DE5YCO0RU) PETROSELINUM CRISPUM (UNII: 1WZA4Y92EX) ALCOHOL (UNII: 3K9958V90M) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54638-0001-1 60 mL in 1 BOTTLE, DROPPER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 08/07/2013 Labeler - ParaDocs All Natural Inc. (008540744) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(54638-0001) , api manufacture(54638-0001) , label(54638-0001) , pack(54638-0001)